Trial Outcomes & Findings for NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (NCT NCT04332653)
NCT ID: NCT04332653
Last Updated: 2026-02-09
Results Overview
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. A SAE was defined as any AE that resulted in any of the following outcomes: 1. Death; 2. A life-threatening AE; 3. An AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; 4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; 5. A congenital anomaly/birth defect; 6. Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
215 participants
Primary outcome timeframe
Up to 2 years and 3 months
Results posted on
2026-02-09
Participant Flow
A total of 215 participants were enrolled in the United States from June 2020 to January 2025.
The trial consisted of a dose escalation phase (Phase 1b) followed by a dose expansion phase (Phase 2a) and a Biomarker Cohort.
Participant milestones
| Measure |
Phase 1b: Dose Level 1 (NT-I7 480 ug/kg)
Participants received NT-I7 as an intramuscular (IM) injection every 6 weeks (Q6W), on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
Checkpoint inhibitor (CPI) treated participants with relapsed/refractory (R/R) triple negative breast cancer (TNBC) received NT-I7 at the recommended phase 2 dose (RP2D= 1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
CPI treated participants with R/R non-small cell lung cancer (NSCLC) received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
CPI treated participants with R/R small cell lung cancer (SCLC) received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
CPI naïve participants with R/R microsatellite stable colorectal cancer (MSS-CRC) received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
CPI naïve participants with R/R pancreatic cancer (PC) received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
CPI naïve participants with R/R ovarian cancer (OC) received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b
STARTED
|
3
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
NOT COMPLETED
|
2
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2a
STARTED
|
0
|
0
|
0
|
16
|
34
|
17
|
29
|
28
|
32
|
34
|
13
|
|
Phase 2a
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase 2a
NOT COMPLETED
|
0
|
0
|
0
|
16
|
34
|
17
|
29
|
28
|
32
|
34
|
12
|
Reasons for withdrawal
| Measure |
Phase 1b: Dose Level 1 (NT-I7 480 ug/kg)
Participants received NT-I7 as an intramuscular (IM) injection every 6 weeks (Q6W), on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an intravenous (IV) infusion every 3 weeks (Q3W), on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
Checkpoint inhibitor (CPI) treated participants with relapsed/refractory (R/R) triple negative breast cancer (TNBC) received NT-I7 at the recommended phase 2 dose (RP2D= 1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
CPI treated participants with R/R non-small cell lung cancer (NSCLC) received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
CPI treated participants with R/R small cell lung cancer (SCLC) received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
CPI naïve participants with R/R microsatellite stable colorectal cancer (MSS-CRC) received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
CPI naïve participants with R/R pancreatic cancer (PC) received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
CPI naïve participants with R/R ovarian cancer (OC) received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b
Death
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
Progressive Disease
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
Withdrawal by Subject
|
1
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2a
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2a
Death
|
0
|
0
|
0
|
9
|
20
|
12
|
18
|
16
|
18
|
24
|
8
|
|
Phase 2a
Lost to Follow-up
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Phase 2a
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Phase 2a
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
3
|
0
|
|
Phase 2a
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
3
|
1
|
2
|
0
|
|
Phase 2a
Withdrawal by Subject
|
0
|
0
|
0
|
4
|
11
|
5
|
9
|
5
|
11
|
4
|
3
|
|
Phase 2a
Miscellaneous
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
Baseline Characteristics
NT-I7 (Efineptakin Alfa) in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1b: Dose Level 1 (NT-I7 480 ug/kg)
n=3 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
n=16 Participants
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=34 Participants
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=17 Participants
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=29 Participants
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
n=28 Participants
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
n=32 Participants
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
n=34 Participants
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=13 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=570 Participants
|
0 Participants
n=19564 Participants
|
0 Participants
n=188924 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=362 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=17 Participants
|
15 Participants
n=96 Participants
|
8 Participants
n=2 Participants
|
26 Participants
n=6 Participants
|
21 Participants
n=2 Participants
|
15 Participants
n=32 Participants
|
16 Participants
n=570 Participants
|
8 Participants
n=19564 Participants
|
131 Participants
n=188924 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=362 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=17 Participants
|
19 Participants
n=96 Participants
|
9 Participants
n=2 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=2 Participants
|
17 Participants
n=32 Participants
|
18 Participants
n=570 Participants
|
5 Participants
n=19564 Participants
|
84 Participants
n=188924 Participants
|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 10.82 • n=362 Participants
|
65.3 years
STANDARD_DEVIATION 10.12 • n=3 Participants
|
54.8 years
STANDARD_DEVIATION 8.21 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 10.75 • n=17 Participants
|
65.2 years
STANDARD_DEVIATION 10.59 • n=96 Participants
|
65.1 years
STANDARD_DEVIATION 6.85 • n=2 Participants
|
54.7 years
STANDARD_DEVIATION 11.25 • n=6 Participants
|
56.1 years
STANDARD_DEVIATION 10.37 • n=2 Participants
|
65.1 years
STANDARD_DEVIATION 10.67 • n=32 Participants
|
64.7 years
STANDARD_DEVIATION 9.49 • n=570 Participants
|
58.1 years
STANDARD_DEVIATION 10.55 • n=19564 Participants
|
60.8 years
STANDARD_DEVIATION 11.08 • n=188924 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=362 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=17 Participants
|
11 Participants
n=96 Participants
|
9 Participants
n=2 Participants
|
10 Participants
n=6 Participants
|
16 Participants
n=2 Participants
|
16 Participants
n=32 Participants
|
12 Participants
n=570 Participants
|
13 Participants
n=19564 Participants
|
109 Participants
n=188924 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=362 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
23 Participants
n=96 Participants
|
8 Participants
n=2 Participants
|
19 Participants
n=6 Participants
|
12 Participants
n=2 Participants
|
16 Participants
n=32 Participants
|
22 Participants
n=570 Participants
|
0 Participants
n=19564 Participants
|
106 Participants
n=188924 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=362 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=2 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=570 Participants
|
0 Participants
n=19564 Participants
|
14 Participants
n=188924 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=362 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=17 Participants
|
31 Participants
n=96 Participants
|
17 Participants
n=2 Participants
|
25 Participants
n=6 Participants
|
24 Participants
n=2 Participants
|
29 Participants
n=32 Participants
|
30 Participants
n=570 Participants
|
13 Participants
n=19564 Participants
|
191 Participants
n=188924 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=570 Participants
|
0 Participants
n=19564 Participants
|
10 Participants
n=188924 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=362 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=570 Participants
|
1 Participants
n=19564 Participants
|
10 Participants
n=188924 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=17 Participants
|
9 Participants
n=96 Participants
|
3 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=32 Participants
|
3 Participants
n=570 Participants
|
3 Participants
n=19564 Participants
|
32 Participants
n=188924 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=570 Participants
|
0 Participants
n=19564 Participants
|
1 Participants
n=188924 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=362 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=17 Participants
|
23 Participants
n=96 Participants
|
13 Participants
n=2 Participants
|
22 Participants
n=6 Participants
|
22 Participants
n=2 Participants
|
27 Participants
n=32 Participants
|
25 Participants
n=570 Participants
|
9 Participants
n=19564 Participants
|
158 Participants
n=188924 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=570 Participants
|
0 Participants
n=19564 Participants
|
1 Participants
n=188924 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=362 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=96 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=570 Participants
|
0 Participants
n=19564 Participants
|
6 Participants
n=188924 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=362 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=96 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=32 Participants
|
2 Participants
n=570 Participants
|
0 Participants
n=19564 Participants
|
7 Participants
n=188924 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=362 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=17 Participants
|
34 Participants
n=96 Participants
|
17 Participants
n=2 Participants
|
29 Participants
n=6 Participants
|
28 Participants
n=2 Participants
|
32 Participants
n=32 Participants
|
34 Participants
n=570 Participants
|
13 Participants
n=19564 Participants
|
215 Participants
n=188924 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years and 3 monthsPopulation: Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. Only participants in Phase 1b were analyzed for this Outcome Measure.
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. A SAE was defined as any AE that resulted in any of the following outcomes: 1. Death; 2. A life-threatening AE; 3. An AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; 4. A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; 5. A congenital anomaly/birth defect; 6. Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=3 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs
TEAEs
|
6 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs
SAEs
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs
Trial Treatment-related TEAEs
|
6 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Phase 1b: Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), Trial Treatment-related TEAEs and Trial Treatment-related SAEs
Trial Treatment-related SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 21 daysPopulation: DLT Evaluable Analysis Set: all participants in Phase 1b portion of the study who were in safety analysis set and have completed the first 21 days (3 weeks) of study treatment (Cycle 1, Day 1 to 21) or any subjects who have not completed 21 days due to DLT.
A DLT was defined as any AE occurring within the first 21 days that was considered to be related to the trial treatments (NT-I7 and/or pembrolizumab) per the investigator, and that met at least one of the non-hematologic or hematologic criteria: * Grade 4 non-hematologic toxicity * Grade ≥ 3 diarrhea, nausea and vomiting * Grade ≥ 3 rash for ≥ 5 days * Grade 4 neutropenia for ≥ 5 days * Febrile neutropenia Grade 3 or Grade 4 * Other Grade 4 hematologic toxicity for ≥7 days, except thrombocytopenia * Any non-hematologic AE ≥ Grade 3 in severity * Any Grade 3 or Grade 4 non-hematologic laboratory value if medical intervention was required, led to hospitalization, persisted for \> 1 week, resulted in potential drug-induced liver injury * Other Grade ≥ 3 clinical laboratory abnormalities not reversible to ≤ Grade 1 within 72 hours * Prolonged delay in initiating Cycle 2 * Any treatment-related toxicity that caused treatment discontinuation in Cycle 1 * Grade 5 toxicity.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=3 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medication (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. Only participants in Phase 2a (Arms I to Va) were analyzed for this Outcome Measure.
ORR was defined as the percentage of participants who had at least one confirmed partial response (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1) and immune RECIST (iRECIST) as determined by the investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=15 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=14 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=26 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
n=27 Participants
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=26 Participants
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=26 Participants
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=26 Participants
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2a (Arms I to Va): Objective Response Rate (ORR)
ORR per RECIST 1.1
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
0 percentage of participants
Interval 0.0 to 23.2
|
0 percentage of participants
Interval 0.0 to 13.2
|
3.7 percentage of participants
Interval 0.1 to 19.0
|
0 percentage of participants
Interval 0.0 to 13.2
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
—
|
—
|
—
|
—
|
|
Phase 2a (Arms I to Va): Objective Response Rate (ORR)
ORR per iRECIST
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
0 percentage of participants
Interval 0.0 to 23.2
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
11.1 percentage of participants
Interval 2.4 to 29.2
|
0 percentage of participants
Interval 0.0 to 13.2
|
7.7 percentage of participants
Interval 0.9 to 25.1
|
3.8 percentage of participants
Interval 0.1 to 19.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-treatment and post-treatment (maximum duration of treatment of approximately 2 years)Population: Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. Only participants with positive CD8 marker were included.
CD8 positivity TILs in tumor biopsy samples were identified using a validated immunohistochemistry (IHC) assay and certified by a pathologist. The percentage of area occupied by TILs was evaluated in the stroma area, tumor area and tumor - relevant tissue area both pre- and post-treatment.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=2 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)
Stroma area: pre-treatment
|
—
|
4.5 percentage of area occupied
Standard Deviation 4.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)
Stroma area: post-treatment
|
—
|
7.5 percentage of area occupied
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)
Tumor area: pre-treatment
|
—
|
0.5 percentage of area occupied
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)
Tumor area: post-treatment
|
—
|
0.5 percentage of area occupied
Standard Deviation 0.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)
Tumor - relevant tissue area: pre-treatment
|
—
|
4.5 percentage of area occupied
Standard Deviation 4.95
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: Percentage of Area Occupied by Tumor-Infiltrating Lymphocytes (TILs)
Tumor - relevant tissue area: post-treatment
|
—
|
12.0 percentage of area occupied
Standard Deviation 11.31
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medication (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. Only participants in Phase 2a (Biomarker Cohort) were analyzed for this Outcome Measure.
ORR was defined as the percentage of participants who had at least one confirmed PR or CR, per RECIST v1.1 and iRECIST as determined by the investigator. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm (\<1 cm). PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=12 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Biomarker Cohort: ORR
ORR per RECIST 1.1
|
—
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: ORR
ORR per iRECIST
|
—
|
16.7 percentage of participants
Interval 2.1 to 48.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trialmedication (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response. Only participants who had a documented response were included.
DOR was defined as the time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=2 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=1 Participants
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=2 Participants
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=3 Participants
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
n=2 Participants
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
n=1 Participants
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=2 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b/2a: Duration of Objective Response (DOR)
DOR per RECIST 1.1
|
—
|
NA months
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
—
|
—
|
—
|
NA months
Interval 4.2 to
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
13.1 months
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
—
|
NA months
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
8.6 months
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
NA months
Interval 7.0 to
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
|
Phase 1b/2a: Duration of Objective Response (DOR)
DOR per iRECIST
|
—
|
NA months
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
—
|
—
|
4.8 months
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
NA months
Interval 4.2 to
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
13.0 months
Interval 13.0 to
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
—
|
NA months
Interval 9.7 to
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
8.6 months
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
NA months
Interval 7.0 to
The median and/or its confidence intervals could not be estimated due to the limited number of events among responders (many participants were censored).
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medications (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response.
DCR was defined as the proportion of participants with a best overall response of CR, PR, stable disease (SD) per RECIST 1.1 and iRECIST as determined by the investigator.. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) at least a 20% increase in the sum of the diameters of target lesions), taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=3 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
n=14 Participants
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=26 Participants
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=15 Participants
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=27 Participants
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
n=26 Participants
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
n=26 Participants
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
n=26 Participants
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=12 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b/2a: Disease Control Rate (DCR)
DCR per RECIST 1.1
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
42.3 percentage of participants
Interval 23.4 to 63.1
|
20.0 percentage of participants
Interval 4.3 to 48.1
|
40.7 percentage of participants
Interval 22.4 to 61.2
|
30.8 percentage of participants
Interval 14.3 to 51.8
|
30.8 percentage of participants
Interval 14.3 to 51.8
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
25.0 percentage of participants
Interval 5.5 to 57.2
|
|
Phase 1b/2a: Disease Control Rate (DCR)
DCR per iRECIST
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
50.0 percentage of participants
Interval 29.9 to 70.1
|
20.0 percentage of participants
Interval 4.3 to 48.1
|
44.4 percentage of participants
Interval 25.5 to 64.7
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
34.6 percentage of participants
Interval 17.2 to 55.7
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
25.0 percentage of participants
Interval 5.5 to 57.2
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medications (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response.
PFS was defined as the time from the first trial treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first per RECIST 1.1 and iRECIST as determined by the investigator. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, using the smallest sum observed on study as reference, with an absolute increase of at least 5 mm, or the appearance of new lesions, or unequivocal progression of non-target lesions, per RECIST 1.1.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=3 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
n=14 Participants
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=26 Participants
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=15 Participants
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=27 Participants
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
n=26 Participants
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
n=26 Participants
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
n=26 Participants
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=12 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b/2a: Progression Free Survival (PFS)
PFS per RECIST 1.1
|
5.3 months
Interval 1.2 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
8.6 months
Interval 1.1 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
1.3 months
Interval 0.9 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
1.2 months
Interval 1.0 to 1.3
|
1.4 months
Interval 1.3 to 4.1
|
1.3 months
Interval 1.2 to 1.4
|
1.7 months
Interval 1.4 to 2.7
|
1.4 months
Interval 1.4 to 1.9
|
1.4 months
Interval 1.3 to 1.4
|
1.3 months
Interval 1.2 to 1.3
|
1.4 months
Interval 1.2 to 1.4
|
|
Phase 1b/2a: Progression Free Survival (PFS)
PFS per iRECIST
|
NA months
Interval 1.4 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
NA months
Interval 1.1 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
NA months
Interval 1.3 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
3.8 months
Interval 1.3 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
4.1 months
Interval 1.4 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
4.0 months
Interval 1.6 to 11.4
|
2.7 months
Interval 1.7 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
7.9 months
Interval 2.4 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
4.4 months
Interval 1.5 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
1.3 months
Interval 1.3 to 2.1
|
4.1 months
Interval 1.3 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Efficacy Evaluable Analysis Set: all participants who received at least one dose of both the trial medications (NT-I7 and Pembrolizumab) and had an evaluable baseline and at least one evaluable post-baseline assessment of tumor response.
OS was defined as the time from first trial treatment (Cycle 1, Day 1) to death from any cause.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=3 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
n=14 Participants
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=26 Participants
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=15 Participants
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=27 Participants
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
n=26 Participants
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
n=26 Participants
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
n=26 Participants
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=12 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b/2a: Overall Survival (OS)
|
NA months
Interval 14.0 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
NA months
Interval 19.2 to
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
9.4 months
The median and/or its confidence interval could not be estimated due to the limited number of events.
|
9.1 months
Interval 3.8 to 10.3
|
17.3 months
Interval 10.5 to 31.0
|
5.9 months
Interval 2.1 to 16.3
|
9.3 months
Interval 7.8 to 18.5
|
16.0 months
Interval 7.1 to 24.0
|
11.1 months
Interval 3.6 to 26.2
|
6.7 months
Interval 2.9 to 10.9
|
10.1 months
Interval 3.7 to 22.9
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications.
Immunogenicity to NT-I7 was measured using a risk-based, tiered testing approach. This included screening and confirmatory assays for binding ADAs, epitope-specific assays to characterize ADA reactivity to whole NT-I7 vs IL-7 domain, and a cell-based neutralizing ADA assay for IL7 bioactivity. Participants' samples were obtained at baseline and over the course of treatment (to evaluate the prevalence and incidence of treatment-emergent/boosted ADA). Not detected or detected but not confirmed ADA was defined as negative. Detected and confirmed ADA was defined as positive.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=3 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 Participants
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
n=16 Participants
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=34 Participants
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=17 Participants
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=29 Participants
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
n=28 Participants
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
n=32 Participants
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
n=34 Participants
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=13 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b/2a: Number of Participants Who Experienced an Increase in Anti-Drug Antibodies (ADAs) to NT-I7
Participants with ADA positive at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Phase 1b/2a: Number of Participants Who Experienced an Increase in Anti-Drug Antibodies (ADAs) to NT-I7
Participants with post-dose ADA positive
|
6 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
24 Participants
|
0 Participants
|
22 Participants
|
19 Participants
|
27 Participants
|
14 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years and 3 monthsPopulation: Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. Only participants in the Biomarker Cohort were analyzed for this Outcome Measure.
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. A SAE was defined as any AE that resulted in any of the following outcomes: Death; A life-threatening AE; An AE that resulted in inpatient hospitalization or prolongation of existing hospitalization for ≥24 hours; A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; A congenital anomaly/birth defect; Important Medical Events (IME) that may not result in death, be life threatening, or require hospitalization may be considered serious when, based upon medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Outcome measures
| Measure |
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=13 Participants
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Biomarker Cohort: Number of Participants Who Experienced TEAEs, SAEs, Trial Treatment-related TEAEs and Trial Treatment-related SAEs
TEAEs
|
—
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: Number of Participants Who Experienced TEAEs, SAEs, Trial Treatment-related TEAEs and Trial Treatment-related SAEs
SAEs
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: Number of Participants Who Experienced TEAEs, SAEs, Trial Treatment-related TEAEs and Trial Treatment-related SAEs
Trial Treatment-related TEAEs
|
—
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Biomarker Cohort: Number of Participants Who Experienced TEAEs, SAEs, Trial Treatment-related TEAEs and Trial Treatment-related SAEs
Trial Treatment-related SAEs
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1b: Dose Level 1 (NT-I7 480 ug/kg)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase 2a: Arm I
Serious events: 4 serious events
Other events: 16 other events
Deaths: 9 deaths
Phase 2a: Arm II
Serious events: 28 serious events
Other events: 34 other events
Deaths: 20 deaths
Phase 2a: Arm III
Serious events: 11 serious events
Other events: 17 other events
Deaths: 12 deaths
Phase 2a: Arm IV
Serious events: 15 serious events
Other events: 29 other events
Deaths: 19 deaths
Phase 2a: Arm IVa
Serious events: 20 serious events
Other events: 27 other events
Deaths: 16 deaths
Phase 2a: Arm V
Serious events: 18 serious events
Other events: 32 other events
Deaths: 18 deaths
Phase 2a: Arm Va
Serious events: 27 serious events
Other events: 34 other events
Deaths: 24 deaths
Phase 2a: Biomarker Cohort
Serious events: 9 serious events
Other events: 13 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Phase 1b: Dose Level 1 (NT-I7 480 ug/kg)
n=3 participants at risk
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 participants at risk
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 participants at risk
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
n=16 participants at risk
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=34 participants at risk
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=17 participants at risk
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=29 participants at risk
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
n=28 participants at risk
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
n=32 participants at risk
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
n=34 participants at risk
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=13 participants at risk
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
4/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.1%
3/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Immune-mediated gastritis
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.6%
7/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.5%
4/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.6%
5/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
41.2%
14/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extradural neoplasm
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
26.5%
9/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
SJS-TEN overlap
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Endocrine disorders
Addisons disease
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
Other adverse events
| Measure |
Phase 1b: Dose Level 1 (NT-I7 480 ug/kg)
n=3 participants at risk
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 2 (NT-I7 960 ug/kg)
n=3 participants at risk
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 1b: Dose Level 3 (NT-I7 1200 ug/kg)
n=6 participants at risk
Participants received NT-I7 as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm I
n=16 participants at risk
CPI treated participants with R/R TNBC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm II
n=34 participants at risk
CPI treated participants with R/R NSCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm III
n=17 participants at risk
CPI treated participants with R/R SCLC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IV
n=29 participants at risk
CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm IVa
n=28 participants at risk
Expansion Cohort. CPI naïve participants with R/R MSS-CRC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm V
n=32 participants at risk
CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Arm Va
n=34 participants at risk
Expansion Cohort. CPI naïve participants with R/R PC received NT-I7 at the RP2D (1200 ug/kg) as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
Phase 2a: Biomarker Cohort
n=13 participants at risk
CPI naïve participants with R/R OC received NT-I7 960 ug/kg as an IM injection Q6W, on Day 1 of alternate cycles (Cycle 1, 3, 5 etc.). Participants received 200 mg Pembrolizumab as an IV infusion Q3W, on Day 1 of every cycle (cycle duration= 21 days).
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site oedema
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site rash
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site warmth
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site induration
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
50.0%
3/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Early satiety
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Axillary pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site nodule
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site swelling
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Malaise
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Device related thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Hernia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Inflammation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site bruising
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site dryness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Performance status decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Vaccination site pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
50.0%
3/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
4/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
29.4%
10/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
48.3%
14/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
31.2%
10/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.5%
8/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
41.4%
12/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
6/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
7/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
6/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.6%
7/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
31.0%
9/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.9%
5/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
21.9%
7/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
3/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.2%
5/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
4/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
6/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.1%
3/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
4/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
4/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Malignant ascites
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
35.3%
6/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
35.7%
10/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
8/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
26.5%
9/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.1%
3/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
24.1%
7/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
8/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.6%
7/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
30.8%
4/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
4/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.2%
5/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
50.0%
3/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.7%
6/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
4/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.6%
7/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
4/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.5%
8/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.5%
4/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
24.1%
7/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
28.6%
8/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
8/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.1%
3/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
4/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
27.6%
8/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
21.4%
6/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
21.9%
7/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.6%
7/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
4/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
3/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
8/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.5%
8/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
30.8%
4/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
3/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Hypohidrosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Skin hypertrophy
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
3/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.9%
5/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
21.9%
7/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
38.5%
5/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
31.2%
5/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
3/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.6%
7/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood creatinine increased
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
3/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.2%
5/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.6%
5/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
3/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
6/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.7%
6/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.6%
5/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.1%
3/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.6%
5/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.1%
3/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood glucose increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Blood iron decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Right ventricular systolic pressure increased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
3/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
3/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
24.1%
7/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.6%
5/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
50.0%
3/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
31.2%
5/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.7%
6/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.9%
5/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.6%
5/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
50.0%
3/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.1%
3/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Autoimmune arthritis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Muscle swelling
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Headache
|
100.0%
3/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.2%
5/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Horners syndrome
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.7%
6/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
21.4%
6/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
6/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
32.4%
11/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
30.8%
4/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
21.4%
6/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Oral candidiasis
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Hypotension
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.6%
7/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.6%
5/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Cyanosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Vena cava embolism
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Vascular disorders
Vena cava thrombosis
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
13.8%
4/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Renal failure
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
66.7%
4/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
25.0%
4/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
41.2%
14/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
47.1%
8/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
44.8%
13/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
42.9%
12/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
37.5%
12/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
47.1%
16/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
30.8%
4/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Pyrexia
|
100.0%
3/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
50.0%
3/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
31.2%
5/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
41.4%
12/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
42.9%
12/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
43.8%
14/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
26.5%
9/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site reaction
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.7%
5/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
3/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
31.0%
9/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
32.1%
9/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
21.9%
7/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
20.6%
7/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
30.8%
4/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
31.2%
5/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.5%
8/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
24.1%
7/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.6%
5/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
26.5%
9/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
23.1%
3/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Chills
|
66.7%
2/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
83.3%
5/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.2%
5/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
21.9%
7/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
18.8%
3/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.2%
5/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
14.3%
4/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
66.7%
4/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.6%
6/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.9%
2/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
66.7%
4/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
4/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Injection site pruritus
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
2/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
2/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
11.8%
2/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
2/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.2%
5/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.7%
3/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
10.3%
3/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
9.4%
3/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
6.2%
1/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
17.2%
5/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.1%
2/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
12.5%
4/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
8.8%
3/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
15.4%
2/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Macular oedema
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
2/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour thrombosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
5.9%
1/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
7.7%
1/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.1%
1/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.6%
1/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
3.4%
1/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
16.7%
1/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
2.9%
1/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
|
Immune system disorders
Hypersensitivity
|
33.3%
1/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/3 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/6 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/16 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/17 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/29 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/28 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/32 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/34 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
0.00%
0/13 • Up to 2 years and 3 months
A TEAE was any AE that starts on/after the first day of trial treatment or that worsens on/after the first day of trial treatment and up to 30 days (90 days for serious adverse events) after the date of last dose of trial drugs, or initiation of new anticancer therapy, whichever is earlier. Safety Analysis Set: all participants who received at least one dose (even partially) of one or both trial medications. For Biomarker Cohort: AEs in this arm were reported as a whole, not by dose level.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place