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) (NCT NCT03221426)
NCT ID: NCT03221426
Last Updated: 2025-07-14
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
1007 participants
Primary outcome timeframe
Up to approximately 75 months
Results posted on
2025-07-14
Participant Flow
Of the 1007 participants that were randomized to trial, 1001 received treatment. At the time of the primary analysis data cut-off, 521 participants are ongoing in the study. Analysis of the remaining 521 enrolled participants will be included in the End of Trial analysis.
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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional 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 post-surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W 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), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
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 post-surgery, participants receive 3 cycles of 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), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
402
|
402
|
100
|
103
|
|
Overall Study
Treated
|
399
|
400
|
99
|
103
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
402
|
402
|
100
|
103
|
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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional 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 post-surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W 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), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
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 post-surgery, participants receive 3 cycles of 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), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|---|---|
|
Overall Study
Ongoing in study
|
212
|
193
|
61
|
55
|
|
Overall Study
Withdrawal by Subject
|
12
|
4
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
1
|
0
|
|
Overall Study
Death
|
174
|
204
|
36
|
45
|
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)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + XP/FP
n=402 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=402 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Pembrolizumab + FLOT Cohort
n=100 Participants
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 post-surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W 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), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + FLOT Cohort
n=103 Participants
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 post-surgery, participants receive 3 cycles of 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), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Total
n=1007 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Adults (between 18 and 64 years)
|
207 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
550 Participants
n=21 Participants
|
|
Age, Customized
From 65 to 84 years
|
194 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
456 Participants
n=21 Participants
|
|
Age, Customized
85 years and older
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
283 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
288 Participants
n=5 Participants
|
287 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
724 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
333 Participants
n=5 Participants
|
321 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
837 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
194 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
395 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
178 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
541 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Geographic Region
Asia
|
190 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
387 Participants
n=21 Participants
|
|
Geographic Region
US
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Geographic Region
Western Europe
|
104 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
325 Participants
n=21 Participants
|
|
Geographic Region
ROW
|
105 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
270 Participants
n=21 Participants
|
|
Tumor Staging
Stage II
|
82 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Tumor Staging
Stage III
|
302 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
748 Participants
n=21 Participants
|
|
Tumor Staging
Stage IVa
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Tumor Staging
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 75 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=402 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=402 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|
|
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
|
44.4 Months
Interval 33.0 to 69.8
|
25.7 Months
Interval 20.8 to 36.5
|
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 based on central review. pathCR is defined as no invasive disease within an entirely submitted and evaluated gross lesion, and histologically negative nodes. The percentage of participants having pathCR is presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=402 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=402 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|
|
Pathological Complete Response (pathCR) Rate - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
13.4 Percentage of Participants
Interval 10.3 to 17.2
|
2.0 Percentage of Participants
Interval 0.9 to 3.9
|
PRIMARY outcome
Timeframe: Up to approximately 75 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=402 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=402 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|
|
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms
|
71.8 Months
Interval 52.5 to
NA = Upper limit was not reached at time of data cut-off due to insufficient number of participants with an event
|
55.7 Months
Interval 41.7 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 70 monthsPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment in the Pembrolizumab+FLOT and Placebo+FLOT Cohort treatment arms, as pre-specified per protocol.
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 the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=99 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=103 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|
|
Number of Participants Who Experience One or More Adverse Events (AEs) - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
99 Participants
|
103 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 17 monthsPopulation: The analysis population consisted of all participants who received ≥1 dose of study treatment in the Pembrolizumab+FLOT and Placebo+FLOT Cohort treatment arms, as pre-specified per protocol.
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 discontinued study treatment due to an AE is presented for the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=99 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=103 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to an AE - Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
37 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsAn 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 will be presented for the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 18 monthsAn 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 the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms separately and in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 75 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 or 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=320 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=306 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|
|
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
|
66.1 Months
Interval 44.9 to
Upper limit not reached at time of data cut-off due to insufficient number of participants with an event
|
44.2 Months
Interval 27.6 to
Upper limit not reached at time of data cut-off due to insufficient number of participants with an event
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, as pre-specified in the 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 in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts.
Outcome measures
| Measure |
Pembrolizumab + XP/FP
n=502 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=505 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|
|
Overall Survival (OS) - Pembrolizumab+XP/FP and Placebo+XP/FP Treatment Arms in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
NA Months
Interval 59.2 to
NA = Median and upper limit were not reached at the data cut-off due to insufficient number of participants with an event
|
55.7 Months
Interval 42.8 to
NA = Upper limit was not reached at the data cut-off due to insufficient number of participants with an event
|
SECONDARY outcome
Timeframe: Up to approximately 75 monthsPopulation: The analysis population consisted of all randomized participants in the Pembrolizumab+XP/FP and Placebo+XP/FP treatment arms in combination with the Pembrolizumab+FLOT and Placebo+FLOT Cohorts, 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 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=502 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=505 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
|---|---|---|
|
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 in Combination With the Pembrolizumab+FLOT and Placebo+FLOT Cohorts
|
47.0 Months
Interval 36.2 to
NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event
|
26.9 Months
Interval 22.1 to 34.7
|
Adverse Events
Pembrolizumab + XP/FP
Serious events: 176 serious events
Other events: 392 other events
Deaths: 181 deaths
Placebo + XP/FP
Serious events: 161 serious events
Other events: 392 other events
Deaths: 206 deaths
Pembrolizumab + FLOT Cohort
Serious events: 66 serious events
Other events: 99 other events
Deaths: 37 deaths
Placebo + FLOT Cohort
Serious events: 51 serious events
Other events: 103 other events
Deaths: 47 deaths
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
Serious events: 242 serious events
Other events: 491 other events
Deaths: 218 deaths
Placebo + XP/FP and Placebo + FLOT Cohort Combined
Serious events: 212 serious events
Other events: 495 other events
Deaths: 253 deaths
Serious adverse events
| Measure |
Pembrolizumab + XP/FP
n=399 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=400 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Pembrolizumab + FLOT Cohort
n=99 participants at risk
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 post-surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W 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), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + FLOT Cohort
n=103 participants at risk
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 post-surgery, participants receive 3 cycles of 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), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
n=498 participants at risk
Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
n=503 participants at risk
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
5/399 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.5%
6/400 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
6/503 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
12/400 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
6/103 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.6%
8/498 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.6%
18/503 • Number of events 18 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Angina unstable
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Coronary artery disease
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Pericardial effusion
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Toxic cardiomyopathy
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Ear and labyrinth disorders
Vertigo
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.0%
8/399 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.6%
8/498 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Endocrine disorders
Hypophysitis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Endocrine disorders
Hypopituitarism
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Endocrine disorders
Hypothyroidism
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.8%
7/400 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.8%
9/503 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Colitis
|
2.8%
11/399 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.4%
12/498 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/503 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
6/399 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.5%
10/400 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.4%
12/498 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.4%
12/503 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Dumping syndrome
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Dysphagia
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
3/99 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Enteritis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastric stenosis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastritis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.25%
1/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Haematochezia
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Ileus
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.25%
1/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Melaena
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
5/399 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.8%
7/400 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
6/498 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.8%
9/503 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Omental infarction
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Stomatitis
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Terminal ileitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.99%
5/503 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
9/399 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
9/400 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.1%
7/99 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.2%
16/498 • Number of events 18 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
11/503 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Adverse drug reaction
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Asthenia
|
0.75%
3/399 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Chest discomfort
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Chest pain
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Fatigue
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
General physical health deterioration
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Generalised oedema
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Hernia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Influenza like illness
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Infusion site reaction
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Malaise
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Mucosal inflammation
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
5/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
6/503 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Oedema peripheral
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Physical deconditioning
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Pyrexia
|
1.0%
4/399 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
5/400 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.1%
7/99 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
11/498 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/503 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Serositis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Sudden death
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Hepatitis
|
1.0%
4/399 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
6/498 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
3/99 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Abdominal infection
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Abscess
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Abscess soft tissue
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Bronchitis
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
COVID-19
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Catheter site infection
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Clostridial sepsis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Device related infection
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Device related sepsis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Diarrhoea infectious
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Diverticulitis
|
0.25%
1/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Empyema
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Gastroenteritis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Herpes zoster
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Infection
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
6/498 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Influenza
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Mediastinal abscess
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Meningitis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Parotitis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Peritonitis
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Pneumonia
|
2.0%
8/399 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.6%
13/498 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/503 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Pneumonia bacterial
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Postoperative abscess
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Pyopneumothorax
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Sepsis
|
1.0%
4/399 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
3/99 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/498 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.99%
5/503 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Septic shock
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Soft tissue infection
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Stoma site abscess
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Urinary tract infection
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
4/99 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Wound infection
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Afferent loop syndrome
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Anastomotic fistula
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
3/99 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Drain site complication
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
1.0%
4/399 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
3/99 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/498 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.99%
5/503 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic stenosis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Glaucoma traumatic
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Stoma obstruction
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Blood creatinine increased
|
1.3%
5/399 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Escherichia test positive
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Neutrophil count decreased
|
1.0%
4/399 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Platelet count decreased
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Transaminases increased
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Weight decreased
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
White blood cell count decreased
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.3%
9/399 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.5%
14/400 • Number of events 15 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
11/498 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.8%
14/503 • Number of events 15 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Fulminant type 1 diabetes mellitus
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/498 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.0%
4/399 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.5%
6/400 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/503 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Steroid diabetes
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal lymphoma
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Cerebral haematoma
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Cerebral infarction
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Headache
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Seizure
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Syncope
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Product Issues
Device dislocation
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Product Issues
Device occlusion
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Psychiatric disorders
Delirium
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
4/399 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Renal and urinary disorders
Nephritis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Renal and urinary disorders
Renal failure
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Renal and urinary disorders
Renal impairment
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Renal and urinary disorders
Renal salt-wasting syndrome
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/498 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal effusion
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fistula
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.5%
6/399 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/498 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
8/399 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
5/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
2/99 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
10/498 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/503 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.60%
3/503 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Embolism
|
1.3%
5/399 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
6/498 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Hypotension
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/498 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Peripheral embolism
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/498 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/498 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.20%
1/503 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
Other adverse events
| Measure |
Pembrolizumab + XP/FP
n=399 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) 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + XP/FP
n=400 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle.
Adjuvant: 4 to 10 weeks post-surgery, participants receive 3 cycles of 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 800 mg/m\^2 via continuous IV infusion on Days 1 to 5 of each 3-week cycle, followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Pembrolizumab + FLOT Cohort
n=99 participants at risk
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 post-surgery, participants receive 3 cycles of pembrolizumab 200 mg via IV infusion Day 1 Q3W 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), followed by pembrolizumab monotherapy 200 mg via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Placebo + FLOT Cohort
n=103 participants at risk
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 post-surgery, participants receive 3 cycles of 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), followed by placebo monotherapy via IV infusion on Day 1 Q3W for up to 11 additional cycles.
|
Pembrolizumab + XP/FP and Pembrolizumab + FLOT Cohort Combined
n=498 participants at risk
Neoadjuvant and adjuvant pembrolizumab+XP/FP and neoadjuvant and adjuvant pembrolizumab+FLOT Cohort treatment arms combined
|
Placebo + XP/FP and Placebo + FLOT Cohort Combined
n=503 participants at risk
Neoadjuvant and adjuvant placebo+XP/FP and neoadjuvant and adjuvant placebo+FLOT Cohort treatment arms combined
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
42.6%
170/399 • Number of events 237 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
39.8%
159/400 • Number of events 213 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
26.3%
26/99 • Number of events 49 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
25.2%
26/103 • Number of events 49 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
39.4%
196/498 • Number of events 286 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
36.8%
185/503 • Number of events 262 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.0%
16/399 • Number of events 27 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
23/400 • Number of events 37 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.9%
5/103 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.2%
21/498 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.6%
28/503 • Number of events 43 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.6%
114/399 • Number of events 198 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.8%
111/400 • Number of events 192 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.3%
27/99 • Number of events 44 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
22.3%
23/103 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
28.3%
141/498 • Number of events 242 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
26.6%
134/503 • Number of events 228 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
19/399 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.5%
26/400 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
4/99 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.8%
7/103 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.6%
23/498 • Number of events 28 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.6%
33/503 • Number of events 41 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Cardiac disorders
Tachycardia
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.6%
8/498 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.99%
5/503 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.3%
29/399 • Number of events 30 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.2%
29/400 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
1/99 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.0%
30/498 • Number of events 31 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
29/503 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Endocrine disorders
Hyperthyroidism
|
3.5%
14/399 • Number of events 15 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
5/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.9%
5/103 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
20/498 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
10/503 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Endocrine disorders
Hypothyroidism
|
8.8%
35/399 • Number of events 37 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.5%
10/400 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.1%
7/99 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.9%
5/103 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.4%
42/498 • Number of events 45 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
15/503 • Number of events 15 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.5%
58/399 • Number of events 101 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
16.8%
67/400 • Number of events 90 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
24.2%
24/99 • Number of events 37 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
30.1%
31/103 • Number of events 54 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
16.5%
82/498 • Number of events 138 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
19.5%
98/503 • Number of events 144 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
20/399 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.5%
30/400 • Number of events 31 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.1%
10/99 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
14.6%
15/103 • Number of events 17 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.0%
30/498 • Number of events 33 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.9%
45/503 • Number of events 48 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
109/399 • Number of events 153 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.8%
111/400 • Number of events 150 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
22.2%
22/99 • Number of events 30 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
31.1%
32/103 • Number of events 44 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
26.3%
131/498 • Number of events 183 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
28.4%
143/503 • Number of events 194 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Diarrhoea
|
37.3%
149/399 • Number of events 221 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
32.8%
131/400 • Number of events 206 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
69.7%
69/99 • Number of events 145 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
72.8%
75/103 • Number of events 175 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
43.8%
218/498 • Number of events 366 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
41.0%
206/503 • Number of events 381 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
11/399 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.5%
10/400 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.1%
7/99 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.6%
18/498 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.8%
14/503 • Number of events 18 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
39/399 • Number of events 60 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.5%
30/400 • Number of events 39 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.7%
11/103 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.8%
44/498 • Number of events 65 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.2%
41/503 • Number of events 51 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Dysphagia
|
5.3%
21/399 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.2%
21/400 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.1%
10/99 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.7%
12/103 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.2%
31/498 • Number of events 35 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.6%
33/503 • Number of events 34 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
7/399 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
5/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
6/103 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.6%
13/498 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
11/503 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.5%
18/399 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
16/400 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.1%
9/99 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.6%
13/103 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.4%
27/498 • Number of events 29 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
29/503 • Number of events 30 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Nausea
|
60.2%
240/399 • Number of events 465 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
61.5%
246/400 • Number of events 500 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
58.6%
58/99 • Number of events 109 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
59.2%
61/103 • Number of events 111 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
59.8%
298/498 • Number of events 574 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
61.0%
307/503 • Number of events 611 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Stomatitis
|
15.8%
63/399 • Number of events 82 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.0%
52/400 • Number of events 68 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
14.1%
14/99 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.7%
9/103 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
15.5%
77/498 • Number of events 98 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.1%
61/503 • Number of events 79 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Gastrointestinal disorders
Vomiting
|
25.6%
102/399 • Number of events 169 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.3%
109/400 • Number of events 177 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
38.4%
38/99 • Number of events 62 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
42.7%
44/103 • Number of events 73 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
28.1%
140/498 • Number of events 231 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
30.4%
153/503 • Number of events 250 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Asthenia
|
21.8%
87/399 • Number of events 155 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
18.8%
75/400 • Number of events 119 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
20.2%
20/99 • Number of events 29 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
19.4%
20/103 • Number of events 27 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
21.5%
107/498 • Number of events 184 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
18.9%
95/503 • Number of events 146 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Chest pain
|
1.8%
7/399 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
9/400 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.9%
5/103 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.4%
12/498 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.8%
14/503 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Chills
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
5/400 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.1%
12/99 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.8%
7/103 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
15/498 • Number of events 19 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.4%
12/503 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Fatigue
|
22.3%
89/399 • Number of events 135 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
23.0%
92/400 • Number of events 127 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
57.6%
57/99 • Number of events 76 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
53.4%
55/103 • Number of events 89 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
29.3%
146/498 • Number of events 211 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
29.2%
147/503 • Number of events 216 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Malaise
|
9.0%
36/399 • Number of events 52 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.5%
42/400 • Number of events 65 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.2%
36/498 • Number of events 52 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.7%
44/503 • Number of events 67 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Mucosal inflammation
|
6.3%
25/399 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.2%
25/400 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.1%
10/99 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.7%
9/103 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.0%
35/498 • Number of events 44 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.8%
34/503 • Number of events 41 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Oedema peripheral
|
4.8%
19/399 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.8%
19/400 • Number of events 24 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.1%
9/99 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.7%
10/103 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.6%
28/498 • Number of events 33 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
29/503 • Number of events 38 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Pyrexia
|
16.3%
65/399 • Number of events 79 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
14.0%
56/400 • Number of events 68 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
25.3%
25/99 • Number of events 43 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
25.2%
26/103 • Number of events 34 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
18.1%
90/498 • Number of events 122 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
16.3%
82/503 • Number of events 102 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
General disorders
Temperature intolerance
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/103 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/503 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
COVID-19
|
0.75%
3/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.50%
2/400 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.6%
8/498 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
6/503 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Oral candidiasis
|
1.0%
4/399 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.8%
9/498 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.6%
8/503 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Pneumonia
|
3.3%
13/399 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.2%
13/400 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.9%
5/103 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.6%
18/498 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.6%
18/503 • Number of events 18 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Infections and infestations
Urinary tract infection
|
1.8%
7/399 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.2%
13/400 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.7%
9/103 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.6%
13/498 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.4%
22/503 • Number of events 25 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.50%
2/399 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.8%
7/103 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.6%
8/498 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.6%
8/503 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.3%
37/399 • Number of events 37 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.0%
36/400 • Number of events 37 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
4/99 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.2%
41/498 • Number of events 41 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.0%
40/503 • Number of events 41 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Injury, poisoning and procedural complications
Wound complication
|
6.3%
25/399 • Number of events 28 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.5%
26/400 • Number of events 27 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/99 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.0%
25/498 • Number of events 28 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.4%
27/503 • Number of events 28 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Alanine aminotransferase increased
|
6.8%
27/399 • Number of events 42 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.5%
26/400 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
17.2%
17/99 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.6%
13/103 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.8%
44/498 • Number of events 64 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.8%
39/503 • Number of events 56 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Aspartate aminotransferase increased
|
7.5%
30/399 • Number of events 43 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.0%
24/400 • Number of events 35 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
15.2%
15/99 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.6%
13/103 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.0%
45/498 • Number of events 63 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.4%
37/503 • Number of events 56 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.3%
9/399 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.5%
10/400 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.1%
8/99 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
6/103 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.4%
17/498 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.2%
16/503 • Number of events 19 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Blood creatinine increased
|
14.0%
56/399 • Number of events 77 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.2%
53/400 • Number of events 88 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.97%
1/103 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.2%
61/498 • Number of events 82 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.7%
54/503 • Number of events 89 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Neutrophil count decreased
|
36.6%
146/399 • Number of events 297 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
32.5%
130/400 • Number of events 244 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
40.4%
40/99 • Number of events 83 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
33.0%
34/103 • Number of events 90 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
37.3%
186/498 • Number of events 380 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
32.6%
164/503 • Number of events 334 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Platelet count decreased
|
11.5%
46/399 • Number of events 82 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
15.0%
60/400 • Number of events 89 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.1%
11/99 • Number of events 24 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.7%
12/103 • Number of events 30 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.4%
57/498 • Number of events 106 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
14.3%
72/503 • Number of events 119 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
Weight decreased
|
27.1%
108/399 • Number of events 111 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
26.0%
104/400 • Number of events 111 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
38.4%
38/99 • Number of events 41 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.2%
28/103 • Number of events 30 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
29.3%
146/498 • Number of events 152 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
26.2%
132/503 • Number of events 141 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Investigations
White blood cell count decreased
|
17.3%
69/399 • Number of events 145 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.2%
53/400 • Number of events 110 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
18.2%
18/99 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
14.6%
15/103 • Number of events 31 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
17.5%
87/498 • Number of events 177 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.5%
68/503 • Number of events 141 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.1%
160/399 • Number of events 259 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
42.2%
169/400 • Number of events 252 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
39.4%
39/99 • Number of events 56 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
33.0%
34/103 • Number of events 43 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
40.0%
199/498 • Number of events 315 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
40.4%
203/503 • Number of events 295 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
13/399 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.8%
11/400 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.1%
8/99 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
6/103 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.2%
21/498 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.4%
17/503 • Number of events 19 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
15/399 • Number of events 17 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
12/400 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.8%
7/103 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
20/498 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.8%
19/503 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.3%
21/399 • Number of events 26 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.5%
18/400 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.1%
8/99 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.8%
7/103 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
29/498 • Number of events 35 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.0%
25/503 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.8%
7/399 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.5%
6/400 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.6%
13/498 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
10/503 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.5%
38/399 • Number of events 52 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.0%
48/400 • Number of events 59 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.1%
11/99 • Number of events 18 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
17.5%
18/103 • Number of events 31 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.8%
49/498 • Number of events 70 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.1%
66/503 • Number of events 90 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.5%
14/399 • Number of events 15 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.2%
17/400 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.1%
12/99 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.2%
26/498 • Number of events 29 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
20/503 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
13/399 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.0%
20/400 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.9%
5/103 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.6%
18/498 • Number of events 27 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.0%
25/503 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.0%
12/399 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
8/400 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.1%
8/99 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
20/498 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
11/503 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
23/399 • Number of events 25 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.5%
18/400 • Number of events 19 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
15.2%
15/99 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.6%
13/103 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.6%
38/498 • Number of events 45 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.2%
31/503 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
18/399 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.2%
21/400 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.1%
9/99 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.6%
13/103 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.4%
27/498 • Number of events 33 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.8%
34/503 • Number of events 37 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.25%
1/399 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.1%
8/99 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.8%
9/498 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.99%
5/503 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
7/399 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
5/400 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.1%
9/99 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.2%
16/498 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/503 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
10/399 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.8%
15/400 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.2%
16/498 • Number of events 19 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.8%
19/503 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Dizziness
|
8.5%
34/399 • Number of events 39 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.0%
36/400 • Number of events 46 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.1%
9/99 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.7%
12/103 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.6%
43/498 • Number of events 51 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.5%
48/503 • Number of events 60 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Dysgeusia
|
11.3%
45/399 • Number of events 52 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.8%
39/400 • Number of events 47 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.1%
13/99 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.7%
12/103 • Number of events 15 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.6%
58/498 • Number of events 68 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.1%
51/503 • Number of events 62 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Headache
|
7.3%
29/399 • Number of events 39 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.5%
30/400 • Number of events 39 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
17.2%
17/99 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.7%
11/103 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.2%
46/498 • Number of events 61 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.2%
41/503 • Number of events 51 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.0%
20/399 • Number of events 24 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.2%
25/400 • Number of events 25 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
20.2%
20/99 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.2%
28/103 • Number of events 31 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.0%
40/498 • Number of events 45 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.5%
53/503 • Number of events 56 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Paraesthesia
|
2.3%
9/399 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.8%
11/400 • Number of events 15 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
19.2%
19/99 • Number of events 26 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.6%
13/103 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.6%
28/498 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.8%
24/503 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
17/399 • Number of events 17 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.0%
20/400 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
21.2%
21/99 • Number of events 29 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
17.5%
18/103 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.6%
38/498 • Number of events 46 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.6%
38/503 • Number of events 43 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/399 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.25%
1/400 • Number of events 1 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
5/498 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.80%
4/503 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Psychiatric disorders
Anxiety
|
1.8%
7/399 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
8/400 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.1%
8/99 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
15/498 • Number of events 17 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
10/503 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Psychiatric disorders
Insomnia
|
11.3%
45/399 • Number of events 48 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.2%
45/400 • Number of events 49 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
18.2%
18/99 • Number of events 20 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.7%
12/103 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.7%
63/498 • Number of events 68 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.3%
57/503 • Number of events 61 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
21/399 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
23/400 • Number of events 23 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
12.1%
12/99 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.7%
10/103 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.6%
33/498 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.6%
33/503 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/498 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
6/503 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
17/399 • Number of events 18 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.8%
7/400 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
14.1%
14/99 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.7%
11/103 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.2%
31/498 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.6%
18/503 • Number of events 18 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
13/399 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
8/400 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.1%
7/99 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.7%
9/103 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
20/498 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.4%
17/503 • Number of events 18 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.0%
28/399 • Number of events 55 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.2%
29/400 • Number of events 58 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.1%
10/99 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.6%
38/498 • Number of events 66 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.4%
32/503 • Number of events 61 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
5/399 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.5%
6/400 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.1%
9/99 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.8%
14/498 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
10/503 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.0%
12/399 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.75%
3/400 • Number of events 3 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.1%
10/99 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.9%
5/103 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.4%
22/498 • Number of events 24 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.6%
8/503 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.50%
2/399 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.00%
0/400 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/498 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
0.40%
2/503 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.5%
6/399 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.8%
7/400 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.9%
3/103 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
11/498 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
10/503 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.5%
22/399 • Number of events 24 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
4.0%
16/400 • Number of events 17 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
30.3%
30/99 • Number of events 33 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
27.2%
28/103 • Number of events 32 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
10.4%
52/498 • Number of events 57 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.7%
44/503 • Number of events 49 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
20/399 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.8%
11/400 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.1%
13/99 • Number of events 14 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.6%
33/498 • Number of events 35 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.0%
15/503 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.5%
6/399 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.0%
4/400 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
6/103 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.4%
12/498 • Number of events 19 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
10/503 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
16.8%
67/399 • Number of events 74 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
14.2%
57/400 • Number of events 68 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
9.7%
10/103 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
14.5%
72/498 • Number of events 79 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.3%
67/503 • Number of events 78 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.8%
59/399 • Number of events 69 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
23/400 • Number of events 28 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
16.2%
16/99 • Number of events 22 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
6/103 • Number of events 7 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
15.1%
75/498 • Number of events 91 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
29/503 • Number of events 35 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.3%
45/399 • Number of events 51 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.5%
30/400 • Number of events 36 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
22.2%
22/99 • Number of events 27 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
11.7%
12/103 • Number of events 13 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
13.5%
67/498 • Number of events 78 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.3%
42/503 • Number of events 49 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.8%
7/399 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.2%
5/400 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.1%
6/99 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.9%
2/103 • Number of events 2 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.6%
13/498 • Number of events 16 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
1.4%
7/503 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
6/399 • Number of events 6 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.0%
8/400 • Number of events 8 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.1%
5/99 • Number of events 5 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.9%
4/103 • Number of events 4 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
11/498 • Number of events 11 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.4%
12/503 • Number of events 12 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Hypertension
|
6.3%
25/399 • Number of events 29 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.5%
30/400 • Number of events 38 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.1%
8/99 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.7%
9/103 • Number of events 15 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
6.6%
33/498 • Number of events 38 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
7.8%
39/503 • Number of events 53 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
|
Vascular disorders
Hypotension
|
5.3%
21/399 • Number of events 21 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
2.2%
9/400 • Number of events 10 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.1%
8/99 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
8.7%
9/103 • Number of events 9 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
5.8%
29/498 • Number of events 30 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
3.6%
18/503 • Number of events 19 • Up to approximately 75 months
All-Cause Mortality includes all randomized participants. Serious and Other adverse events (AEs) includes all randomized participants who received ≥1 dose of study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Per protocol, AEs are presented for the XP/FP and FLOT treatment arms separately and in combination.
|
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