Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension (NCT NCT04882241)
NCT ID: NCT04882241
Last Updated: 2025-06-12
Results Overview
EFS is based on RECIST 1.1 as assessed by the investigator and is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), are not considered EFS events.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
Up to approximately 42 months
Results posted on
2025-06-12
Participant Flow
120 participants were included in the China subpopulation. At the time of the primary analysis data cut-off, 94 participants are ongoing in the study. The FLOT cohort was not enrolled in China per specifications in the protocol Supplemental Statistical Analysis Plan (sSAP) amendment and no data were collected for the FLOT cohort in China.
Participant milestones
| Measure |
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
Adjuvant: 4 to 10 weeks postsurgery, participants receive pembrolizumab 200 mg via IV infusion Day 1 Q3W for up to 11 cycles PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
|
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
Adjuvant: 4 to 10 weeks postsurgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
59
|
61
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
59
|
61
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pembrolizumab + XP/FP
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
Adjuvant: 4 to 10 weeks postsurgery, participants receive pembrolizumab 200 mg via IV infusion Day 1 Q3W for up to 11 cycles PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
|
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
Adjuvant: 4 to 10 weeks postsurgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
|
|---|---|---|---|---|
|
Overall Study
Ongoing in study
|
46
|
48
|
0
|
0
|
|
Overall Study
Death
|
13
|
13
|
0
|
0
|
Baseline Characteristics
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)-China Extension
Baseline characteristics by cohort
| Measure |
Pembrolizumab + XP/FP
n=59 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=61 Participants
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + FLOT Cohort
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin (calcium folinate) 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
Adjuvant: 4 to 10 weeks postsurgery, participants receive pembrolizumab 200 mg via IV infusion Day 1 Q3W for up to 11 cycles PLUS docetaxel 50 mg/m\^2, oxaliplatin 85 mg/m\^2, 5FU 2600 mg/m\^2, and leucovorin 200 mg/m\^2 Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
|
Placebo + FLOT Cohort
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
Adjuvant: 4 to 10 weeks postsurgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS docetaxel 50 mg/m\^2 via IV infusion, oxaliplatin 85 mg/m\^2 via IV infusion, 5FU 2600 mg/m\^2 via IV infusion, and leucovorin 200 mg/m\^2 via IV infusion Q2W (on Days 1 and 15 of Cycle 1; Day 8 of Cycle 2, and Day 1 of Cycle 3) for 4 administrations.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Adults (between 18 and 64 years)
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Age, Customized
From 65 to 84 years
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Tumor Staging
Stage II
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Tumor Staging
Stage III
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Tumor Staging
Stage IVa
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Geographic Region
Asia
|
59 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 42 monthsPopulation: The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms, as pre-specified per protocol.
EFS is based on RECIST 1.1 as assessed by the investigator and is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by computer tomography (CT) scan or biopsy if indicated (for participants who are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), are not considered EFS events.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=59 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=61 Participants
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Event-free Survival (EFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
NA Months
Interval 15.2 to
NA = Median and upper limit were not reached at time of data cut-off due to insufficient number of participants with an event
|
36.5 Months
Interval 15.5 to
NA = Upper limit was not reached at time of data cut-off due to insufficient number of participants with an event
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 9 weeks following completion of neoadjuvant treatment (up to Study Week 18)Population: The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms, as pre-specified per protocol.
PathCR rate is defined as the percentage of participants having a pathCR. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=59 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=61 Participants
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
6.8 Percentage of Participants
Interval 1.9 to 16.5
|
4.9 Percentage of Participants
Interval 1.0 to 13.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 42 monthsPopulation: The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms, as pre-specified per protocol.
OS is defined as the time from randomization to death due to any cause. OS is presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=59 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=61 Participants
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
NA Months
NA = Median, lower limit, and upper limit were not reached at time of data cut-off due to insufficient number of participants with an event
|
NA Months
Interval 25.8 to
NA = Median and upper limit were not reached at time of data cut-off due to insufficient number of participants with an event
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 42 monthsPopulation: The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol Supplemental Statistical Analysis Plan (sSAP) amendment and no data were collected for the FLOT cohort in China.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to approximately 17 monthsPopulation: The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE is presented for Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms. The FLOT cohort was not enrolled in China per specifications in the protocol Supplemental Statistical Analysis Plan (sSAP) amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=59 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=61 Participants
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Number of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
59 Participants
|
61 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 23 monthsPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented for Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=59 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=61 Participants
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms Separately and in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
12 Participants
|
8 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms who had surgery, as pre-specified per protocol.
DFS is defined as the time from post-surgery baseline scan until the first occurrence of local/distant recurrence or death from any cause and is based on RECIST 1.1 as assessed by the investigator.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=42 Participants
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=42 Participants
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
FLOT=docetaxel+oxaliplatin+5FU+leucovorin (calcium folinate). Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|
|
Disease-free Survival (DFS) Per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
NA Months
Interval 15.2 to
NA = Median and upper limit were not reached at time of data cut-off due to insufficient number of participants with an event
|
33.1 Months
Interval 16.6 to
NA = Upper limit was not reached at time of data cut-off due to insufficient number of participants with an event
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.
OS is defined as the time from randomization to death due to any cause. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 42 monthsPopulation: The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.
EFS is based on RECIST 1.1 as assessed by the investigator and is defined as the time from randomization to the first of the following events: radiographic disease progression per RECIST 1.1; local or distant recurrence as assessed by CT scan or biopsy if indicated (for participants who are disease free after surgery); clinical progression as evidenced by peritoneal carcinomatosis confirmed by preoperative laparoscopy or laparotomy (for participants who are confirmed to be free of peritoneal involvement by laparoscopy at screening); or death due to any cause. A second primary malignancy, or radiographic progressive disease (PD) during the neoadjuvant phase that does not preclude successful surgery (i.e., disease free after surgery), are not considered EFS events. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. There is no FLOT cohort in China to combine with XP/FP arms.
Outcome measures
Outcome data not reported
Adverse Events
Pembrolizumab + XP/FP
Serious events: 32 serious events
Other events: 59 other events
Deaths: 13 deaths
Placebo + XP/FP
Serious events: 30 serious events
Other events: 61 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Pembrolizumab + XP/FP
n=59 participants at risk
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=61 participants at risk
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hypopituitarism
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Enteritis
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Obstruction gastric
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Volvulus
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
13.1%
8/61 • Number of events 9 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Ulcer
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Abdominal infection
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Abdominal sepsis
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Device related infection
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Haematological infection
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Infection
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
8.5%
5/59 • Number of events 5 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic stenosis
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
6.8%
4/59 • Number of events 5 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight decreased
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
10.2%
6/59 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Cerebral infarction
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Epilepsy
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Renal impairment
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/59 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Phlebitis
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab + XP/FP
n=59 participants at risk
XP=cisplatin+capecitabine and FP=cisplatin+5-fluorouracil. Neoadjuvant: Prior to surgery, participants receive 3 cycles of pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets twice each day (BID) on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5-fluorouracil (5FU) via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive pembrolizumab 200 mg via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
Placebo + XP/FP
n=61 participants at risk
Neoadjuvant: Prior to surgery, participants receive 3 cycles of placebo (normal saline solution) via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive placebo via IV infusion on Day 1 Q3W PLUS cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and capecitabine 1000 mg/m\^2 via oral tablets BID on Days 1 to 14 of each 3-week cycle OR cisplatin 80 mg/m\^2 via IV infusion on Day 1 Q3W and 5FU via continuous IV infusion on Days 1 to 5 of each 3-week cycle for up to 3 cycles.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
76.3%
45/59 • Number of events 85 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
77.0%
47/61 • Number of events 85 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
8.5%
5/59 • Number of events 5 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.2%
6/59 • Number of events 9 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 9 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.8%
4/59 • Number of events 8 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.1%
3/59 • Number of events 6 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
18.6%
11/59 • Number of events 17 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.2%
6/59 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
8/59 • Number of events 10 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
16.4%
10/61 • Number of events 11 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.2%
5/61 • Number of events 5 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
25.4%
15/59 • Number of events 18 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
29.5%
18/61 • Number of events 18 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.2%
19/59 • Number of events 24 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
11.5%
7/61 • Number of events 10 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.2%
6/59 • Number of events 8 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.2%
5/61 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
76.3%
45/59 • Number of events 100 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
80.3%
49/61 • Number of events 120 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
62.7%
37/59 • Number of events 72 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
50.8%
31/61 • Number of events 67 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Asthenia
|
1.7%
1/59 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.2%
5/61 • Number of events 6 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Fatigue
|
16.9%
10/59 • Number of events 11 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.2%
5/61 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Malaise
|
6.8%
4/59 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
25.4%
15/59 • Number of events 18 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
16.4%
10/61 • Number of events 15 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
23.7%
14/59 • Number of events 15 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
14.8%
9/61 • Number of events 11 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
11.5%
7/61 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.6%
8/59 • Number of events 14 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
20.3%
12/59 • Number of events 12 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
21.3%
13/61 • Number of events 13 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
28.8%
17/59 • Number of events 26 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
19.7%
12/61 • Number of events 16 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
28.8%
17/59 • Number of events 27 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
21.3%
13/61 • Number of events 15 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.2%
6/59 • Number of events 6 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
10.2%
6/59 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
15.3%
9/59 • Number of events 13 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood urea increased
|
3.4%
2/59 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 8 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
C-reactive protein increased
|
6.8%
4/59 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.5%
5/59 • Number of events 6 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Lymphocyte count decreased
|
28.8%
17/59 • Number of events 32 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
14.8%
9/61 • Number of events 19 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
79.7%
47/59 • Number of events 125 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
82.0%
50/61 • Number of events 171 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
52.5%
31/59 • Number of events 79 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
57.4%
35/61 • Number of events 76 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
SARS-CoV-2 test positive
|
6.8%
4/59 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight decreased
|
39.0%
23/59 • Number of events 24 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
55.7%
34/61 • Number of events 36 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
76.3%
45/59 • Number of events 138 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
75.4%
46/61 • Number of events 168 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.4%
25/59 • Number of events 31 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
47.5%
29/61 • Number of events 39 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.3%
9/59 • Number of events 10 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
9.8%
6/61 • Number of events 8 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.8%
4/59 • Number of events 8 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 5 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
10.2%
6/59 • Number of events 10 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.8%
4/59 • Number of events 9 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 8 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
47.5%
28/59 • Number of events 48 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
29.5%
18/61 • Number of events 24 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
22.0%
13/59 • Number of events 19 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
14.8%
9/61 • Number of events 13 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.4%
15/59 • Number of events 35 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
21.3%
13/61 • Number of events 23 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.9%
7/59 • Number of events 12 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
23.7%
14/59 • Number of events 30 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
14.8%
9/61 • Number of events 13 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.9%
7/59 • Number of events 10 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
16.9%
10/59 • Number of events 17 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
18.0%
11/61 • Number of events 16 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Malnutrition
|
8.5%
5/59 • Number of events 5 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
11.9%
7/59 • Number of events 10 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.2%
5/61 • Number of events 8 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Headache
|
5.1%
3/59 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
6.8%
4/59 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 1 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
3.3%
2/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 4 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/61 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.9%
7/59 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
8.2%
5/61 • Number of events 5 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
3/59 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
1.6%
1/61 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.6%
11/59 • Number of events 12 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
4.9%
3/61 • Number of events 3 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
3.4%
2/59 • Number of events 2 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
6.6%
4/61 • Number of events 7 • Up to approximately 42 months
All-Cause Mortality includes all randomized participants. Serious and Other AEs includes all randomized participants who received ≥1 dose of study treatment. The FLOT cohort was not enrolled in China per specifications in the protocol sSAP amendment and no data were collected for the FLOT cohort in China. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER