Trial Outcomes & Findings for Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies (NCT NCT04181788)
NCT ID: NCT04181788
Last Updated: 2026-04-27
Results Overview
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with first line (1L) and second line (2L) non-small cell lung cancer (NSCLC) (Phase 2). For the Phase 1b, any of the following AEs occurring during the DLT observation period (the first cycle of treatment) which were attributable to the investigational product were classified as DLTs: Grade 5 AE not clearly due to the underlying disease or extraneous causes; Hematologic toxicity; Non-Hematologic Toxicity; Delay of ≥ 3 weeks in receiving the next scheduled administration due to persisting treatment-related toxicities.
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
155 participants
Phase 1b: at the end of cycle 1 (28 days) for the PF-06801591 300 mg SC Q4W arms, and (42 days) for the PF-06801591 600 mg SC Q6W arms
2026-04-27
Participant Flow
Participant milestones
| Measure |
Phase 1b Escalation 300 mg SC Q4W
PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 300 mg SC Q4W
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
|
Phase 1b Escalation 600 mg SC Q6W
PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 600 mg SC Q6W
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8.
|
Phase 2 300 mg SC Q4W
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 28.
|
Phase 2 600 mg SC Q6W
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 18.
|
|---|---|---|---|---|---|---|
|
TREATMENT
STARTED
|
4
|
12
|
6
|
12
|
41
|
80
|
|
TREATMENT
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
TREATMENT
NOT COMPLETED
|
4
|
12
|
6
|
12
|
41
|
80
|
|
FOLLOW-UP
STARTED
|
3
|
9
|
6
|
7
|
20
|
49
|
|
FOLLOW-UP
COMPLETED
|
3
|
8
|
4
|
2
|
9
|
22
|
|
FOLLOW-UP
NOT COMPLETED
|
0
|
1
|
2
|
5
|
11
|
27
|
Reasons for withdrawal
| Measure |
Phase 1b Escalation 300 mg SC Q4W
PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 300 mg SC Q4W
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
|
Phase 1b Escalation 600 mg SC Q6W
PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 600 mg SC Q6W
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8.
|
Phase 2 300 mg SC Q4W
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 28.
|
Phase 2 600 mg SC Q6W
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 18.
|
|---|---|---|---|---|---|---|
|
TREATMENT
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
3
|
5
|
|
TREATMENT
Other unspecified
|
0
|
0
|
0
|
0
|
0
|
2
|
|
TREATMENT
Ongoing
|
0
|
3
|
0
|
5
|
7
|
15
|
|
FOLLOW-UP
Death
|
0
|
0
|
1
|
2
|
8
|
20
|
|
FOLLOW-UP
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
2
|
|
FOLLOW-UP
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
FOLLOW-UP
Other unspecified
|
0
|
1
|
0
|
0
|
0
|
3
|
|
FOLLOW-UP
Ongoing
|
0
|
0
|
1
|
3
|
2
|
2
|
|
TREATMENT
Adverse Event
|
0
|
2
|
1
|
0
|
1
|
3
|
|
TREATMENT
Death
|
0
|
0
|
0
|
0
|
8
|
8
|
|
TREATMENT
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
|
TREATMENT
Progressive disease
|
3
|
3
|
5
|
7
|
20
|
38
|
|
TREATMENT
Global deterioration of health status
|
0
|
2
|
0
|
0
|
2
|
8
|
Baseline Characteristics
Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1b Expansion 300 mg SC Q4W
n=12 Participants
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
|
Phase 1b Escalation 600 mg SC Q6W
n=6 Participants
PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 600 mg SC Q6W
n=12 Participants
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8.
|
Phase 2 300 mg SC Q4W
n=41 Participants
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 28.
|
Phase 2 600 mg SC Q6W
n=80 Participants
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 18.
|
Total
n=155 Participants
Total of all reporting groups
|
Phase 1b Escalation 300 mg SC Q4W
n=4 Participants
PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9.
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
65 - <75 years
|
5 Participants
n=240 Participants
|
1 Participants
n=236 Participants
|
4 Participants
n=702 Participants
|
17 Participants
n=211 Participants
|
21 Participants
n=76 Participants
|
49 Participants
n=401 Participants
|
1 Participants
n=226 Participants
|
|
Age, Continuous
|
57.3 Years
STANDARD_DEVIATION 15.78 • n=240 Participants
|
62.7 Years
STANDARD_DEVIATION 10.33 • n=236 Participants
|
62.4 Years
STANDARD_DEVIATION 10.02 • n=702 Participants
|
63.9 Years
STANDARD_DEVIATION 11.75 • n=211 Participants
|
62.9 Years
STANDARD_DEVIATION 10.62 • n=76 Participants
|
62.6 Years
STANDARD_DEVIATION 11.33 • n=401 Participants
|
62.0 Years
STANDARD_DEVIATION 13.29 • n=226 Participants
|
|
Age, Customized
<65 years
|
7 Participants
n=240 Participants
|
4 Participants
n=236 Participants
|
6 Participants
n=702 Participants
|
18 Participants
n=211 Participants
|
48 Participants
n=76 Participants
|
85 Participants
n=401 Participants
|
2 Participants
n=226 Participants
|
|
Age, Customized
75 - <85 years
|
0 Participants
n=240 Participants
|
1 Participants
n=236 Participants
|
2 Participants
n=702 Participants
|
5 Participants
n=211 Participants
|
10 Participants
n=76 Participants
|
19 Participants
n=401 Participants
|
1 Participants
n=226 Participants
|
|
Age, Customized
≥85 years
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
1 Participants
n=211 Participants
|
1 Participants
n=76 Participants
|
2 Participants
n=401 Participants
|
0 Participants
n=226 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=240 Participants
|
3 Participants
n=236 Participants
|
3 Participants
n=702 Participants
|
9 Participants
n=211 Participants
|
14 Participants
n=76 Participants
|
39 Participants
n=401 Participants
|
4 Participants
n=226 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=240 Participants
|
3 Participants
n=236 Participants
|
9 Participants
n=702 Participants
|
32 Participants
n=211 Participants
|
66 Participants
n=76 Participants
|
116 Participants
n=401 Participants
|
0 Participants
n=226 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=401 Participants
|
0 Participants
n=226 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=240 Participants
|
6 Participants
n=236 Participants
|
12 Participants
n=702 Participants
|
41 Participants
n=211 Participants
|
80 Participants
n=76 Participants
|
155 Participants
n=401 Participants
|
4 Participants
n=226 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=401 Participants
|
0 Participants
n=226 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
34 Participants
n=211 Participants
|
62 Participants
n=76 Participants
|
96 Participants
n=401 Participants
|
0 Participants
n=226 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=401 Participants
|
0 Participants
n=226 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=240 Participants
|
6 Participants
n=236 Participants
|
12 Participants
n=702 Participants
|
7 Participants
n=211 Participants
|
18 Participants
n=76 Participants
|
59 Participants
n=401 Participants
|
4 Participants
n=226 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=401 Participants
|
0 Participants
n=226 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=240 Participants
|
0 Participants
n=236 Participants
|
0 Participants
n=702 Participants
|
0 Participants
n=211 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=401 Participants
|
0 Participants
n=226 Participants
|
PRIMARY outcome
Timeframe: Phase 1b: at the end of cycle 1 (28 days) for the PF-06801591 300 mg SC Q4W arms, and (42 days) for the PF-06801591 600 mg SC Q6W armsPopulation: DLT-evaluable analysis set included all participants who received at least 1 dose of study treatment in the Phase 1b and either experienced DLT during the DLT-evaluation period or completed the DLT-evaluation period without DLT.
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with first line (1L) and second line (2L) non-small cell lung cancer (NSCLC) (Phase 2). For the Phase 1b, any of the following AEs occurring during the DLT observation period (the first cycle of treatment) which were attributable to the investigational product were classified as DLTs: Grade 5 AE not clearly due to the underlying disease or extraneous causes; Hematologic toxicity; Non-Hematologic Toxicity; Delay of ≥ 3 weeks in receiving the next scheduled administration due to persisting treatment-related toxicities.
Outcome measures
| Measure |
Phase 1b Escalation 300 mg SC Q4W
n=3 Participants
PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 300 mg SC Q4W
n=11 Participants
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
|
Phase 1b Escalation 600 mg SC Q6W
n=6 Participants
PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 600 mg SC Q6W
n=12 Participants
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8.
|
|---|---|---|---|---|
|
Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Phase 2: Cycle 4 Day 1, 8, 15, 22 and Cycle 5 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1, 8, 15, 29 and Cycle 4 Day 1 for the PF-06801591 600 mg SC Q6W armPopulation: Phase 2: The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 reportable concentration measurement. Safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here "Number of participants analyzed" signifies participants who had data available for this outcome measure.
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCτ is area under the plasma concentration-time profile from time zero to the next dose (at steady state, starting at Week 12). (τ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen)
Outcome measures
| Measure |
Phase 1b Escalation 300 mg SC Q4W
n=23 Participants
PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 300 mg SC Q4W
n=49 Participants
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
|
Phase 1b Escalation 600 mg SC Q6W
PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 600 mg SC Q6W
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8.
|
|---|---|---|---|---|
|
Phase 2: AUCτ of PF-06801591 at Steady State
|
20800 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 54
|
48090 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 47
|
—
|
—
|
PRIMARY outcome
Timeframe: Phase 2: Cycle 4 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1 for the PF-06801591 600 mg SC Q6W armPopulation: Phase 2: The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 reportable concentration measurement. Safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here "Number of participants analyzed" signifies participants who had data available for this outcome measure.
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12)
Outcome measures
| Measure |
Phase 1b Escalation 300 mg SC Q4W
n=24 Participants
PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 300 mg SC Q4W
n=55 Participants
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
|
Phase 1b Escalation 600 mg SC Q6W
PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 600 mg SC Q6W
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8.
|
|---|---|---|---|---|
|
Phase 2: Ctrough of PF-06801591 at Steady State, at Week 12
|
21.48 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 60
|
23.95 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 74
|
—
|
—
|
SECONDARY outcome
Timeframe: Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day).This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day).Laboratory results were classified according to the NCI-CTCAE criteria version 5.0. Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care (ADL); Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 1 to Grade 4 laboratory abnormalities were reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Cycle 1 Day 1, 8, 15, 22, Cycle 2 Day 1; for the PF-06801591 600 mg SC Q6W arms, Cycle 1 Day 1, 8, 15, 29, Cycle 2 Day 1This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCτ is area under the plasma concentration-time profile from time zero to the next dose (after single dose). (τ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Phase 1b/2: Cycle 2 Day 1 for all ArmsThis study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Ctrough is pre-dose concentration after single dose (first dose).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Day 1 of Cycle 4; for the PF-06801591 600 mg SC Q6W arms, Day 1 of Cycle 3This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Phase 1b/2: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10 and end of treatment (EOT) for the PF-06801591 300 mg SC Q4W arms; Day 1 of Cycle 1, 2, 3, 4, 5, 7 and EOT for the PF-06801591 600 mg SC Q6W armsThis study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Treatment-induced ADA = Baseline ADA titer was missing or negative and participant had ≥1 post-treatment positive ADA titer (ADA titer greater than or equal to 99 with assay cut-point of 1.09). Treatment-induced NAb = Baseline NAb titer was missing or negative or ADA-negative and participant had ≥1 post-treatment positive NAb titer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Phase 1b/2: Up to 30 monthsThis study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). OR was defined as confirmed best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1. Complete Response (CR): Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). All target lesions must be assessed. Partial Response (PR): Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Phase 1b/2: Up to 30 monthsThis study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). TTR was defined for participants with confirmed objective response (CR or PR) as the time from the 'start date' to the date of first documentation of objective tumor response which is subsequently confirmed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Phase 1b/2: Baseline up to 30 monthsThis study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). OR was defined as confirmed BOR of CR or PR according to RECIST v1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). All target lesions must be assessed. PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. PD-L1 expression was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest that are defined by tumor cell morphology.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1b Escalation 300 mg SC Q4W
Phase 1b Expansion 300 mg SC Q4W
Phase 1b Escalation 600 mg SC Q6W
Phase 1b Expansion 600 mg SC Q6W
Phase 2 300 mg SC Q4W
Phase 2 600 mg SC Q6W
Serious adverse events
| Measure |
Phase 1b Escalation 300 mg SC Q4W
n=4 participants at risk
PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 300 mg SC Q4W
n=12 participants at risk
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
|
Phase 1b Escalation 600 mg SC Q6W
n=6 participants at risk
PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 600 mg SC Q6W
n=12 participants at risk
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8.
|
Phase 2 300 mg SC Q4W
n=41 participants at risk
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 28.
|
Phase 2 600 mg SC Q6W
n=80 participants at risk
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 18.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Inappropriate antidiuretic
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Disease progression
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Phase 1b Escalation 300 mg SC Q4W
n=4 participants at risk
PF-06801591 300 mg was given subcutaneously (SC) every 4 weeks (Q4W) (Cycles are 28 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 300 mg SC Q4W
n=12 participants at risk
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 20.
|
Phase 1b Escalation 600 mg SC Q6W
n=6 participants at risk
PF-06801591 600 mg was given SC every 6 weeks (Q6W) (Cycles are 42 days in length). The maximum number of cycles was 9.
|
Phase 1b Expansion 600 mg SC Q6W
n=12 participants at risk
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 8.
|
Phase 2 300 mg SC Q4W
n=41 participants at risk
PF-06801591 300 mg was given SC Q4W (Cycles are 28 days in length). The maximum number of cycles was 28.
|
Phase 2 600 mg SC Q6W
n=80 participants at risk
PF-06801591 600 mg was given SC Q6W (Cycles are 42 days in length). The maximum number of cycles was 18.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
4/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
6/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.5%
8/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
10/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hyperthyroidism
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
5/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.5%
6/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Hyperthermia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Injection site reaction
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Malaise
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pain
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
4/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
General disorders
Swelling
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
5/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.5%
6/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood corticotrophin increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
4/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Cortisol decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Free thyroxine index increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
5/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Red blood cell count increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Thyroid hormones decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Total bile acids increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.5%
8/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.5%
10/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
Weight increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
19.5%
8/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
10.0%
8/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
4/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
4/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
33.3%
4/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
6.2%
5/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.5%
2/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
1.2%
1/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.3%
3/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.8%
7/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
4.9%
2/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
14.6%
6/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
22.0%
9/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
13.8%
11/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
9.8%
4/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
3.8%
3/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
12.2%
5/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
4/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
3/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
2/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
7.5%
6/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
25.0%
3/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
5.0%
4/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
2.4%
1/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
16.7%
1/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/4 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
8.3%
1/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/6 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/12 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/41 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/80 • Phase 1b/2: On-treatment period (defined as the time from the first dose of study treatment through minimum [30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day] for the treatment-emergent adverse events (TEAEs); Baseline up to 30 months for all-causality mortality.
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER